ISTH Academy

OC 24.1

The Influence of Renal Impairment on Clinical Outcomes in Venous Thromboembolism Patients Enrolled in GARFIELD-VTE

S. Goto¹, A.G.G. Turpie², A. Zaghdoun³, J.I. Weitz⁴, S. Haas⁵, W. Ageno⁶, S.Z. Goldhaber⁷, P. Angchaisuksiri⁸, J. Dalsgaard Nielsen⁹, G. Kayani³, S. Schellong¹⁰, H. Bounameaux¹¹, L.G. Mantovani¹², P. Prandoni¹³, A.K. Kakkar³, on behalf of the GARFIELD-VTE Investigators
¹Tokai University School of Medicine, Department of Medicine (Cardiology), Tokai, Japan, ²McMaster University, Hamilton, Canada, ³Thrombosis Research Institute, London, United Kingdom, ⁴McMaster University and Thrombosis and Atherosclerosis Research Institute, Ontario, Canada, ⁵Formerly Technical University of Munich, Munich, Germany, ⁶University of Insubria, Department of Medicine and Surgery, Varese, Italy, ⁷Harvard Medical School, Boston, United States, ⁸Ramathibodi Hospital, Mahidol University, Department of Medicine, Bangkok, Thailand, ⁹Copenhagen University Hospital, Copenhagen, Denmark, ¹⁰Municipal Hospital Dresden, Medical Department 2, Dresden, Germany, ¹¹University Hospital of Geneva, Faculty of Medicine, Geneva, Switzerland, ¹²University degli Studi di Milano Bicocca, Milan, Italy, ¹³Arianna Foundation on Anticoagulation, Bologna, Italy

Main Topic: Venous Thromboembolism
Category: DOACs

Background: Venous thromboembolism (VTE) patients with concomitant chronic kidney disease (CKD) represent a complex patient group, with an increased risk of thrombosis as well as serious bleeding complications. Moreover, anticoagulation is challenging because the majority of anticoagulant drugs are excreted by kidney.
Aims: Compare the baseline characteristics, treatment patterns, and 12-month outcomes between patients with moderate-to-severe (stages 3-5) CKD and patients with normal-to-mild (stages 1-2) CKD enrolled in the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE.
Methods: GARFIELD-VTE (ClinicalTrials.gov: NCT02155491) is a global, prospective, non-interventional study of real-world treatment practices. 10,685 patients with objectively confirmed VTE were enrolled between May 2014 and January 2017, 8,939 of which (normal-to-mild CKD n=6897, moderate-to-severe CKD n=2042) were eligible for analysis in this study.
Results: The distribution of VTE events was comparable between groups (moderate-to-severe CKD: 57.1% deep vein thrombosis (DVT) alone, 42.9% pulmonary embolism (PE) ± DVT; normal-to-mild: 58.9% DVT alone, 41.1% PE ± DVT). Moderate-to-severe CKD (vs. normal-to-mild CKD) was more common in females (57.0% vs. 47.0%). Moderate-to-severe CKD patients were older; mean (standard deviation) 67.4 (14.8) years vs. 56.1 (16.6) years, but BMI; mean (standard deviation) was comparable to patients with normal-to-mild CKD: 29.2 (6.9) kg/m² vs. 28.1 (6.5) kg/m², respectively. Chronic heart failure (6.8% vs. 2.2%), chronic immobilisation (7.1% vs. 5.3%) and a history of cancer (17.2% vs. 12.9%) were all more common in moderate-to-severe CKD patients compared to normal-to-mild CKD patients, respectively. No clinically meaningful differences were found between treatment patterns at baseline between groups (Table 1). Over 12-months follow-up, patients with moderate-to-severe CKD were at an increased risk (hazard ratio [95% confidence interval]) of all-cause mortality (1.92 [1.63-2.26]), major bleeding (1.94 [1.41-2.68]), and recurrent VTE (1.27 [1.02-1.57]) (Table 2).
Conclusions: VTE patients with moderate-to-severe CKD are at an increased risk of major adverse outcomes.